JP2020519411A - Wound closure system - Google Patents

Abstract

The wound suturing system (2) comprises a device having a first body (4) and a second body (6). Each of the first body (4) and the second body (6) has an adhesive backing (20). The first body (4) is coupled to the second body (6) by an adjustable connector (8). The adjustable connector (8) is allowed to move in a single direction. When an injury occurs, the first body and the second body (4, 6) are placed on opposite sides of the wound (22) and then pulled together to seal the wound (22).

Description

(Cross-reference of related applications)
This application claims the benefit of US Provisional Patent Application No. 62/504,020, filed May 10, 2017. The entire disclosure of the above application is incorporated herein by reference.

(Technical field)
FIELD OF THE DISCLOSURE The present disclosure relates to wound suturing systems, and more particularly, to adjustable devices for wound suturing.

The suturing of wounds such as cuts has traditionally been accompanied by stitches or staples. The technique of properly stitching a wound takes years to master. Unfortunately, the average person does not know how to properly stitch a wound in an emergency. Moreover, stitches and staples are not adjustable. When the wound becomes inflamed, the stitches can break and the wound can tear.

Furthermore, surgeons who use retention sutures to suture morbidly obese patients may expose the patient to complications such as severe pain and withdrawal at the injury site.

There are numerous other devices known for wound closure. These known devices are capable of suturing and protecting wounds, stopping or preventing bleeding, and minimizing the potential for secondary infections. Examples of such a device include a bandasco or a butterfly banda. However, these bands are generally only suitable for minor cuts and scratches, and generally not for suturing serious wounds.

Another known wound suturing device is described in US Pat. In particular, Belson et al. disclose a device for suturing surgical incisions that includes a plurality of suturing components that laterally join the left and right base panels together. A plurality of left and right shaft supports are coupled to each base panel. When the panels are pushed together and approached, the panels engage each other to suture the wound.

There is a continuing need for a wound closure system that can be used with minimal training for both light and severe injuries. Desirably, the wound suturing system can be stably attached to a patient and can be quickly adjusted to suture the wound quickly and cleanly.

US Pat. No. 9,050,086

As disclosed herein, it can be used with minimal training for both light and severe injuries, can be stably attached to the patient, and can be quickly used to quickly and cleanly suture a wound. An adjustable wound closure system was unexpectedly found.

In one embodiment, the wound suturing system has a first body and a second body. Each of the first body and the second body has an adhesive backing. The first body is connected to the second body by an adjustable connector. The first body and the second body are attached to the adjustable connector at the sloped wall. The wall has a slope to produce a downward force when tension is present between the first body and the second body, which keeps the body attached to the patient's body. To help you. The adjustable connector includes or is connected to a suturing mechanism that allows movement of the adjustable connector in only one direction. Thus, when the adjustable connector is pulled, the adjustable connector pulls both the first body and the second body and prevents any rearward movement. During operation, this is effective for suturing wounds.

A wide variety of adjustable connectors are contemplated within the scope of the present disclosure. The adjustable connector can be a knotted cord or rope that only allows movement in a single direction. The adjustable connector can also be a cord or rope coupled to a unidirectional structure that includes an object having an opening with teeth, where the teeth have some rearward tension. When you do, it will mesh with the cord. Further, the adjustable connector can be a barbed cord coupled to a locking mechanism with internal protrusions or a surface with a bevel, the locking mechanism being such that the barbed cord is only unidirectional. Allows you to move. The adjustable connector can also be a cable tie or any other mechanism selected by the skilled person that causes movement in a single direction.

In operation, the wound closure system functions by peeling or otherwise removing the protective cover from the adhesive backing and adhering the first and second bodies to the patient on both sides of the wound. The first body and the second body are also oriented to ensure that the outer surfaces of the sloped walls of the first body and the second body face each other. When the body is placed against the patient's skin, the user pulls the adjustable connector and brings the first and second bodies closer together until the wound is sutured. Also, for large lacerations, multiple of the wound suturing systems can be distributed in series along the length of the wound and used in series.

In another embodiment, the inner surfaces of the sloping walls of the first body and the second body can face downward toward the patient's skin. This orientation produces a downward force, which helps to keep the body attached while pinching the skin adjacent the wound together.

In a further embodiment, the wound suturing system can also include an opening configured to connect with the staple on both the first body and the second body. This allows the wound suturing system to be applied in situations where the adhesive is not suitable or cannot be used.

In another embodiment, the wound suturing system can have a first body with fingers and a second body configured to connect to a plurality of adjustable connectors called "fingers". Both bodies are manufactured for use in a kit together for ease of handling, for example, provided separately in rolls or temporarily connected and provided in rolls, separated. It is possible to The first body and the second body include an adhesive backing and a removable adhesive cover. The finger is attached to the first body and selectively couples the first body to the second body.

During operation, the adhesive cover is removed and the first and second bodies are placed on opposite sides of the wound. The first body is moved toward the second body by pulling on the fingers until the wound is sutured. Once the wound is sealed, the fingers of the first body are attached to the second body. The fingers can be attached to the second body using, for example, hook and loop fastener material. The fingers allow the cuts to be ventilated while preventing separation of the wound.

Advantageously, the wound suture system can be engaged and used as an independent wound suture system during the entire period of wound healing, or as a temporary support on lacerations or surgical incisions. Can be used. Also, multiple wound suturing devices may be used in series to suture very long wounds. Moreover, the wound suturing system provides the surgeon with the ability to provide a tension adjustment system to assist morbidly obese patients in resolving the complications caused by retention sutures during surgical or post-surgical suturing.

The above as well as further advantages of the present invention will become apparent to those skilled in the art from the following description of preferred embodiments, when considered in light of the accompanying drawings.

FIG. 6 is a top right perspective view of a wound suturing system, according to an embodiment of the invention, depicting a single wound suturing device with an adhesive backing. FIG. 2 is an upper left perspective view of the wound suturing system shown in FIG. 1. FIG. 2 is a side view of the wound suturing system shown in FIG. 1. 2 is a top view of the wound suturing system shown in FIG. 1. FIG. FIG. 2 is a bottom view of the wound suturing system shown in FIG. 1 with a portion of the removable liner peeled away to reveal the underlying adhesive. FIG. 2 is a top perspective view of the wound suturing system shown in FIG. 1 and showing the open wound covered and attached to the patient's skin. FIG. 2 is a top perspective view of the wound suturing system shown in FIG. 1 and further shown covering a wound sutured by a wound suturing device and adhering to the patient's skin. FIG. 6 is a top perspective view of a wound suturing system according to another embodiment of the disclosure, including multiple wound suturing devices and a single suture line for simultaneous operation of the wound suturing devices. FIG. 6 is a partial side view showing a slipknot for use in the wound suturing system of the present disclosure. FIG. 6 is a partial side view showing a slipknot for use in the wound suturing system of the present disclosure. FIG. 3 is a perspective view of a suturing mechanism used in a suture line of the wound suturing system of the present disclosure. FIG. 3 is a perspective view of a suturing mechanism used in a suture line of the wound suturing system of the present disclosure. FIG. 3 is a side view showing a suture line with beaded beads for use in the wound suturing system of the present disclosure. FIG. 6 is a side view of a wound suturing system according to yet another embodiment of the invention, depicting a wound suturing device with an adhesive backing and fingers connecting the first body and the second body. FIG. 11 is a top view of the wound suturing system shown in FIG. 10 and further shown covering a wound sutured by a wound suturing device and adhering to the patient's skin.

The following detailed description and the accompanying drawings describe and illustrate various exemplary embodiments of the present invention. The description and drawings serve to enable those skilled in the art to make and use the invention and are not intended to limit the invention to any embodiment. With respect to the disclosed methods, the steps presented are exemplary in nature and, thus, the order of steps is neither essential nor critical.

In the description, “lower”, “upper”, “horizontal”, “vertical”, “upper”, “lower”, “top”, “bottom”, “top”, and Relative terms such as "bottom" and their derivatives (eg, "horizontally," "downward," "upwardly," etc.) may be referred to as such or related drawings. It is understood to refer to the direction as shown in. These relative terms are for convenience of description and do not require that the device be configured or operated in any particular orientation. Attachment terms such as "connected", "connecting", "coupled", "coupled", and "coupled" are used interchangeably and refer to one structure or Refers to one surface being affixed to another structure or another surface.

With reference to FIGS. 1 to 8, a wound suturing device 2 according to the present invention has a first body 4 and a second body 6 attached by an adjustable connector 8. The wound suturing instrument 2 is used for stably suturing a wound of a patient such as a cut or a dehiscence.

The first body 4 and the second body 6 are formed of any rigid or semi-rigid material suitable for medical applications. As a non-limiting example, the first body 4 and the second body 6 may be formed from a thermoplastic material such as nylon, polyethylene, polypropylene. Also, a thermoplastic vulcanizate may be utilized. Also considered are biodegradable materials, and especially materials that can be bioabsorbed over time during implantation and after sufficient healing of the wound.

As shown in FIGS. 1-8, each of the first body 4 and the second body 6 may have a first portion 17 and a second portion 18. As a non-limiting example, the first portion 17 may be formed from a rigid or semi-rigid thermoplastic material and the second portion 18 may be a flexible plastic or a foam rubber material or the like. It may be formed of a rubber material. The first and second portions 18 may be co-molded and physically secured to each other, or may be separately formed and connected by adhesive or mechanical fasteners. One of ordinary skill in the art may select suitable materials and combinations of materials for the first body 4 and the second body 6 of the wound suturing device 2 of the present disclosure, as desired.

Adjustable connector 8 is flexible so that wound closure device 2 can be used with a wide variety of wounds. As a non-limiting example, the adjustable connector 8 is attached to a fastener that allows only movement in one direction, as shown, for example, in FIGS. 9A-9E and further described below, It may be a rope, cord, knotted cord, or cable tie. Also, other suitable types of adjustable connectors 8 may be utilized within the scope of the present disclosure, as desired.

As shown in FIGS. 1-8, both the first body 4 and the second body 6 adhere the bodies 4, 6 to the patient's skin 100 (shown in FIGS. 6-7 and 11). It has a sex backing 20. The adhesive backing 20 may also be optionally covered by a protective cover 21, allowing the protective cover 21 to be stripped from the adhesive backing 20 prior to attachment to the patient's skin. For example, the adhesive backing may be 3M 1510, 3M 1522, 3M 1577, 3M 9832, 3M 9877, 3M 9917, 3M 9880, and 3M cyanoacrylate glue or medical adhesive tape such as 3M 1524, or a skilled person. It may be any other adhesive selected by

Referring to FIG. 6, it is possible to apply the adhesive directly to the skin, or the protective cover of the adhesive backing 20 may be removed and the first body 4 and the second body 6 are opened. It may rest on the patient's skin on both sides of the wound 22. The adjustable connector 8 is then pulled using the knob or gripping the mechanism 7 in the direction indicated by the arrow shown in FIG. The bodies 4, 6 adhered to the skin are then drawn together in the direction indicated by the arrow in FIG. 7 until the wound 22 is sutured. Once the wound 22 is sutured, the medical professional may further use stitches or sealants to seal the wound, if desired.

In addition to this, the first body 4 and the second body 6 can have openings (not shown) for accommodating staples. Additionally or alternatively, the second portions 18 of the first body 4 and the second body 6 are also soft and flexible, such as foam rubber through which staples can penetrate. It may be formed from the material having. In such a case, the bodies 4, 6 would be placed on either side of the wound and then stapled in place to yield a better grip.

In an emergency, the patient can bleed seriously, which can prevent the adhesive from joining the skin. In such a situation, the use of staples penetrating the main bodies 4 and 6 enables medical personnel to stably attach the main bodies 4 and 6 to the skin. Once the bodies 4,6 are placed against the skin, the cord or gripping mechanism 7 is used to pull the cord 8 and draw the bodies 4,6 together until the wound 22 is sutured. Once the wound 22 is sutured, a medical professional can use stitches or sealants to seal the wound 22.

1-5, a wound suturing device 2 according to certain embodiments of the present disclosure attaches a first body 4 and a second body 6 by means of an adjustable connector 8 in the form of a rope or cord. You may let me. In this embodiment, the cord 8 is tied in the form of a knot 30, such as the slip knot or the uni-slip knot shown in FIGS. 9A and 9B, which allows the cord 8 to move in only one direction. The knot 30 allows the cord 8 to be tensioned between the two bodies 4, 6 and prevents the cord from relaxing. Both the first body 4 and the second body 6 have an adhesive backing 20 which is removed leaving only the adhesive that attaches the bodies 4, 6 to the skin.

In this embodiment, the first body 4 further comprises a housing 12 with a slope. The beveled housing 12 is defined by the beveled wall 10 and a downwardly extending rear portion 11 that produces a substantially triangular or tent-shaped object used to house the knot 30. May be. The second body 6 also has a wall 10 with a slope. The sloping walls 10 of the first body 4 and the second body 6 act to direct the downward force generated by the tension between the two bodies when the adjustable connector 8 is pulled. This results in a larger grip and a higher surface tension on the skin.

Furthermore, each of the sloped walls 10 of the first body 4 and the second body 6 includes at least one opening 14 through which the adjustable connector 8 is provided. The beveled wall 10 of the first body 4 has a single opening 14 that is appropriately dimensioned to allow the adjustable connector 8 to be provided with double penetration. You may. The sloped wall 10 of the second body 6 is two openings 14, for example, the adjustable connector 8 passes through the two openings 14 of the sloped wall 10 of the second body 6. It may have two openings 14 which allow it to be looped together. This looping of the adjustable connector through both openings 14 of the second body 6 secures the adjustable connector 8 to the second body 6.

The downwardly extending rear part 11 of the sloping housing 12 of the first body 4 may also have a single opening 16 through which the adjustable connector 8 is likewise provided. It should be understood that only that portion of the adjustable connector 8 that is configured to be grasped and pulled by the user may be provided through the single opening 16 in the rear portion 11.

Importantly, the single opening 16 is angled so that the knot 30 (or a corresponding suturing mechanism, described further below) does not pull through the single opening 16 when the adjustable connector 8 is pulled. Has a diameter smaller than the diameter of the knot 30 contained in the housing 12 having. During operation, when the adjustable connector 8 is manually pulled, the knot 30 will abut the inner surface of the beveled housing 12. This allows the first body 4 and the second body 6 to be irreversibly pulled towards each other when the knot 30 is tightened by this pulling of the adjustable connector 8.

The knot 30 shown in FIGS. 1-5 and 9A-9B replaces another type of suturing mechanism that allows unidirectional movement of the adjustable connector 8 and thereby prevents the cord from slipping back. It should be understood that it may be done. For example, as shown in FIGS. 9C-9D, the suturing mechanism 34 may include a body having a central opening and a plurality of beveled teeth 35. The orientation of the teeth 35 ensures that the adjustable connector 8, such as a cord or suture, can only be pulled in a single direction through the central opening of the suturing mechanism 34. When the cord 8 is subjected to rearward tension, the teeth 35 mesh with the cord 8 and prevent the cord 8 from moving rearward. In operation, when the adjustable connector 8 is manually pulled, the suturing mechanism 34 will abut the inner surface of the beveled housing 12. This causes the first body 4 and the second body 6 to move relative to each other when the adjustable connector 8 is pulled through the central opening of the suturing mechanism 34 and the single opening 16 of the beveled housing 12. It becomes possible to pull irreversibly.

In yet another example, the adjustable connector 8 and knot 30 may be replaced by a barbed cord 9 and locking mechanism 27 as shown in FIG. 9E. The knotted cord 9 may be attached to the sloped wall 10 on the second body 6. The sloping wall 10 or the downwardly extending rear part 11 on the first body 4 is integrated or connected to a one-way locking mechanism 27 which allows the cord to move in only one direction. May be. For example, the locking mechanism 27 has diagonal flexibility that allows the individual nodes to be pulled forward, but prevents the individual nodes from moving backwards through the locking mechanism 27. It may have a set of protrusions (not shown). In operation, when the user wishes to apply the wound suturing device 2, the adhesive backing 20 is removed and the bodies 4, 6 are placed adjacent to each other on either side of the wound 22. A knob or grasping mechanism 7 is used to pull the knotted cord 9, which causes the bodies 4, 6 to pull the skin together until the wound 22 is sutured. In that case, the responder can then use stitches or sealants to tie and close the wound 22.

The wound suturing device 2 has been described above with respect to a single device used to suture the wound 22, but using the wound suturing device 2 in series, as shown in FIG. It should be understood that it is possible to suture. A plurality of wound suturing systems 2 are arranged with the bodies 4, 6 of the wound suturing system 2 on either side of the laceration 22. Each adjustable connector 8 of the wound suturing system 2 can be connected to a single pull line 40, for example, to facilitate simultaneous operation of all wound sutures along the length of the wound 22. is there. As shown in FIG. 8, the wound suturing system 2 is then operated to suture the laceration 22.

9A and 9B show a series of steps for making a suitable knot 30 for use in the wound suturing system 2 of the present disclosure. These knots 30 allow the adjustable connector 8 to move in one direction while preventing the adjustable connector 8 from moving in the opposite direction. FIG. 9A is a description of the procedure for tying slip knots, while FIG. 9B is a description of the procedure for tying uni slip knots. Other unidirectional knots are also contemplated and are within the scope of the present disclosure.

9C and 9D show the teeth 35 that allow the adjustable connector 8 to pass in one direction, but when the adjustable connector 8 is pulled in the opposite direction, the teeth 35 mesh with the adjustable connector 8 and are allowed. 3 shows a suturing mechanism 34 with teeth 35 for fixing the adjustment connector 8 in place.

FIG. 9E shows an additional embodiment of a wound suturing device 2 that allows the first and second bodies 4 and 6 to approach each other while preventing the posterior movement thereof. It is attached by a cord 9 with a knot to be moved.

10 and 11 show a further embodiment of a wound suturing device 2'according to the present disclosure. Structures similar or related to those shown in FIGS. 1-9E are identified in FIGS. 10 and 11 with the same numbers and primes (') for the sake of brevity.

As shown in FIG. 10, the wound suturing device 2'has a first body 4'and a second body 4'. The first body 4'extends outwardly from the first body 4'and is configured with a plurality of adjustable connectors or fingers configured to be removably connected or tied to the second body 6'. 8'. Overall, the first body 4'and the second body 6'can be used to suture a wound 22', for example as shown in FIG.

Each of the first body 4'and the second body 6'is rolled into a compact form suitable for dispersion and storage and is separated from the roll, cut or ruptured for its intended use. It is possible to manufacture it as a single strip of material with individual pieces. The first body 4'and the second body 6'have an adhesive backing 20' and a removable protective cover (not shown). During operation, the protective cover is removed and the first backing 20' is firstly held so that the first backing 4'and the second backing 6'stable hold the first body 4'and the second body 6'in place on the patient's skin 100'. The body 4'and the second body 6'are located on opposite sides of the wound 22'.

The first body 4'is then moved towards the second body 6', for example by pulling on at least one of the fingers 8', until the wound 22' is sutured. When the wound 22' is sealed, the fingers 8'of the first body 4'are attached to the second body 6'.

In a particular example, the fingers 8'can be attached to the second body 6'by the use of hook and loop fasteners 42'. The hook and loop fasteners 42' may be provided on the lower surface of the fingers 8'of the first body 4'and on the upper surface of the second body 6'. The fitting of the hook and loop fastener material 42' enables the first body 4'to be selectively, stably and reversibly attached to the second body 6'. The fingers 8'connected by hook and loop fasteners also allow the wound 22' to be vented while preventing separation of the wound.

Advantageously, the wound suturing instrument 2, 2'of the present disclosure can be used with minimal training to be stably attached to a patient. The wound closure devices 2, 2'are also adjustable, can be applied quickly and cleanly, and can be used for a wide variety of wound types.

While specific exemplary embodiments and details have been set forth for the purpose of illustrating the invention, various changes may be made without departing from the scope of the disclosure, which is further described in the claims set forth below. It will be apparent to those skilled in the art.

Claims (20)

A wound suturing device,
A first body and a second body, each of the first body and the second body having an adhesive backing;
An adjustable connector coupling the first body to the second body, wherein each of the first body and the second body has a first wall, and the adjustable connector is An adjustable connector that extends through the first wall and is unidirectionally pullable to suture the wound. The wound suturing instrument of claim 1, wherein the first body and the second body include an adhesive backing. The wound closure device of claim 1, wherein the first wall of the second body includes two openings configured to receive an adjustable connector. The wound closure device of claim 1, wherein the first wall of the first body includes a single opening configured to receive the adjustable connector. The wound closure device of claim 4, wherein the first body includes a downwardly extending posterior portion depending from the first wall of the first body. The wound closure device of claim 5, wherein the posterior portion includes a second opening configured to receive the adjustable connector. The front wall and the rear portion of the first body define a beveled housing containing the unidirectional structure of the adjustable connector, the unidirectional structure including the unidirectional structure. 7. The wound closure device of claim 6, which allows the adjustment connector to be pulled in only one direction. The wound closure device of claim 7, wherein the adjustable connector is a cord and the unidirectional structure is a knot. The wound suturing device according to claim 8, wherein the knot is a slip knot or a uni slip knot. 8. The wound closure device of claim 7, wherein the adjustable connector is a cord and the unidirectional structure is a suturing mechanism that includes a body having a central hole and beveled teeth. The adjustable connector is a barbed cord and the unidirectional structure is an object having a protrusion that allows the barb of the barbed cord to move only in the single direction through the body. The wound suturing device according to claim 7, which is The wound suturing instrument of claim 1, wherein the first body and the second body are configured to accommodate staples. The first body and the second body each have a first portion and a second portion, and the first portion is fixed to the second portion. Wound suture instrument. 14. The wound closure device of claim 13, wherein the first portion is formed of a rigid or semi-rigid thermoplastic material and the second portion is formed of a flexible plastic or rubber material. The wound suturing device according to claim 14, wherein the second portion is formed of foam rubber. A wound suturing system comprising a plurality of wound suturing devices according to claim 1, arranged in series along the length of the wound. 17. The system of claim 16, further comprising a single suture or draw line connected to each of the adjustable connectors for simultaneous operation of the wound closure device. A method of suturing a wound,
A first body and a second body, each of the first body and the second body having an adhesive backing; the first body and the second body; and the first body. An adjustable connector for coupling the first body and the second body each having a first wall portion, wherein the adjustable connector has the first wall. Providing a wound suturing instrument including an adjustable connector that is provided through the portion and is allowed to be pulled in a single direction;
Applying the first body and the second body to the patient on both sides of the wound so that the first walls of the first body and the second body face each other;
Tensioning the adjustable connector by pulling the adjustable connector on the first body and pulling the first and second bodies together until the wound is sutured. Including the method. Further comprising a plurality of the wound suturing devices arranged in series along the length of the wound, pulling the adjustable connector to provide a single suture connected to each of the adjustable connectors or 19. The method of claim 18, comprising pulling a pull line. A wound suturing device,
A first body and a second body, each of the first body and the second body having an adhesive backing;
A plurality of adjustable connectors attached to the first body and selectively coupling the first body to the second body, the adjustable connector comprising the first body. A hook-and-loop fastener provided on the lower surface of the adjustable connector attached to the, and a hook-and-loop fastener provided on the upper surface of the second body, the adjustable connector A plurality of adjustable connectors that can be pulled to be sutured and selectively coupled to the second body by the hook and loop fasteners.

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